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The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

1. Xia® 3 Spinal System
   The Xia® 3 Spinal System is comprised of screws, blockers, and hooks that affix rods and connectors to vertebrae of the spinal column for purposes of stabilization, or corrective action through the application of force.

2. Xia® 4.5 Spinal System
   The Xia® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduction screws, hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, and cross connectors to vertebrae of the spinal column.

The provided document is a 510(k) premarket notification for the Stryker Spine Xia® 3 and Xia® 4.5 Spinal Systems. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing or data analysis.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices for an expansion of indications for use.

Here's why and what information is available:

The document explicitly states:

• "This submission seeks to build upon predicate Xia® 3 and Xia® 4.5 Spinal Systems through expansion of indications only. Therefore, no additional performance data is necessary." (Page 6, "Summary of Performance Data")

This means the submission is not presenting new performance studies or acceptance criteria for a novel device or a significantly modified device. Instead, it's arguing that the expanded indications for the Xia® 3 and Xia® 4.5 Spinal Systems are substantially equivalent to the indications already cleared for a primary predicate device (Medtronic Sofamor Danek, CD HORIZON® Spinal System cleared under K140276) and previous versions of the Xia® systems.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document as no new performance data was deemed necessary for this submission. The device is implicitly accepted based on its substantial equivalence to predicate devices, which would have undergone performance testing during their original clearance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new performance studies were conducted for this 510(k). The document only mentions predicate device clearances.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a spinal fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relies on the safety and effectiveness demonstrated by its predicate devices for its original indications and argues that the expanded indications are within the scope of what was already established for similar, legally marketed devices. It is a regulatory submission for a spinal implant, which typically doesn't involve the kind of performance studies (e.g., diagnostic accuracy, reader studies) that would generate the detailed data requested in your prompt regarding acceptance criteria, sample sizes, and expert ground truth for an AI/diagnostic device.

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The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fustion using autograft in skeletally mature patients in the following acute and chronic instabilities or deformities:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• . Spondy lolisthesis;
• Trauma (i.e. fracture or dislocation); -
• Spinal stenosis: -
• . Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor; •
• Pseudoarthrosis; and
• Failed previous fusion .

The Ø5.5mm rods from the Stryker Spinal System and Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System."

When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® 3 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Stryker Spine XIA® 3 Spinal System is a noncervical pedicle screw system comprised of monoaxial and polyaxial bone screws, blocking mechanism), rods, hooks, and connectors. The implants are manufactured from Ti6Al4V alloy, CP Ti, and CoCrMo alloy (Vitallium).

Here's an analysis of the provided text regarding the acceptance criteria and study for the XIA® 3 Spinal System:

The provided document is a 510(k) Summary for the Stryker Spine XIA® 3 Spinal System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics. Therefore, the information you're asking for, particularly quantitative acceptance criteria and detailed study designs involving human readers or standalone algorithm performance, is not present in this document.

Instead, the document focuses on:

• Indications for Use: What the device is intended to treat.
• Device Description: What the device is made of and its components.
• Predicate Devices: Other similar devices already on the market.
• Substantial Equivalence Justification: How the new device is similar to the predicates.

Let's break down what is available and what is not:

Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with corresponding device performance metrics in the way one would expect from a performance study demonstrating efficacy (e.g., sensitivity, specificity, accuracy for a diagnostic device, or a specific functional outcome for a therapeutic device).

Instead, the "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to predicate devices. The performance is reported in terms of mechanical testing results that show compliance with established ASTM standards.

Missing Information (Not found in the provided document):

The following specific information about a study to prove the device meets acceptance criteria, particularly in the context of AI or diagnostic performance, is not present in this 510(k) submission:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for a performance study is described. The "testing" refers to mechanical integrity and engineering analysis.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is a spinal implant for mechanical fixation, not a diagnostic device requiring expert consensus on ground truth.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a diagnostic or AI device. The ground truth for this device's performance would be successful mechanical integration and stability within the human body, which is assessed through long-term clinical outcomes (not detailed here, but likely referenced in the clinical literature analysis) and through pre-clinical mechanical testing standards.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

Summary:

The provided document is a 510(k) summary for a spinal implant system (XIA® 3 Spinal System). The goal of this submission is to demonstrate substantial equivalence to already cleared devices, not to establish novel safety and effectiveness through new clinical trials with detailed performance metrics characteristic of diagnostic or AI-driven devices.

The "study" that proves the device meets (implicit) acceptance criteria consists of:

• Mechanical testing: Static and dynamic compression bending, static torsion (per ASTM F1717-04), and interconnection strength (per ASTM F1798-97).
• Engineering analyses: Dimensional comparisons to predicate devices.
• Clinical literature analysis: To support the intended use and safety/effectiveness history of similar devices.

Therefore, the specific types of questions relating to AI performance, reader studies, ground truth establishment, and training/test sets are not relevant to this particular 510(k) submission for a mechanical spinal implant and are consequently not answered within the provided text.

Ask a specific question about this device

The Stryker Spine XIA 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
• Spondylolisthesis;
• Trauma (i.e., fracture or dislocation);
• Spinal Stenosis:
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis; and
• Failed previous fusion.

The Ø5.5 mm titanium and Vitallium rods from the Stryker Spine Radius® Spinal System and Ø6.0 mm Vitallium rods from XIA Spinal System are intended to be used with the other components of XIA® 3 Spinal System.

This 510(k) is intended to introduce an extension to the existing Xia 3 Spinal System. The proposed line extension includes the addition of titanium Uniplanar Screws, titanium Uniplanar Reduction Screws, and use of the Stryker Spine Radius Ø5.5 mm Vitallium® rod with the Xia® 3 Spinal System.

The provided text is for a Special 510(k) Premarket Notification for a spinal system (Xia 3 Spinal System – Line Extension), which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering analysis and performance testing for mechanical properties and biocompatibility, not clinical studies or AI/software performance evaluations.

Therefore, the specific information requested in your prompt (acceptance criteria for a device's performance often related to AI/software, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is not typically applicable or found in this type of 510(k) submission for a physical medical implant.

The document does state:

• Study performed: "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the Stryker Spine Xia 3 Spinal System."

However, it does not provide the specific details about:

1. Acceptance criteria and reported device performance (in a table): The document only generally states that testing was completed for compliance.
2. Sample sizes used for the test set and data provenance: Not applicable, as this refers to engineering tests, not a clinical data test set.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study or effect size of AI improvement: Not applicable, as this is a physical implant, not an AI-assisted diagnostic tool.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of clinical expert consensus. For engineering testing, the "ground truth" would be established mechanical properties or design specifications.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a "line extension" for an existing spinal fixation system. The "study" mentioned refers to engineering tests and analysis to ensure the new components meet established mechanical and material safety standards as per FDA guidance for spinal systems. It does not involve performance evaluation in the context of AI or diagnostic accuracy, which is what most of your questions pertain to.

Ask a specific question about this device

The Stryker Spine XIA 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
• . Spondylolisthesis;
• Trauma (i.e., fracture or dislocation); ●
• . Spinal Stenosis;
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
• Tumor; .
• . Pseudoarthrosis; and
• Failed previous fusion. .

The Ø5.5 mm rods from the Stryker Spine Radius Spinal System and Ø6.0 mm Vitallium rods from XIA Spinal System are intended to be used with the other components of XIA 3 Spinal System.

This 510(k) is intended to introduce an extension to the existing Xia® 3 Spinal System. The proposed line extension includes the addition of various screws, connectors and a hook.

This document is a 510(k) premarket notification for a medical device called the Stryker Spine XIA 3 Spinal System - Line Extension. It details the regulatory approval process and describes the device's intended use and technological characteristics. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving those criteria are met for an AI-powered medical device.

The provided text focuses on:

• Regulatory classification and approval: It states the device is substantially equivalent to existing predicate devices.
• Device description: It describes the Stryker Spine XIA 3 Spinal System as a spinal fixation system, its components, and its intended use for various spinal conditions in non-cervical regions.
• Predicate devices: It lists other Stryker Spine systems and a Moss Miami System as predicates.
• Technological characteristics summary: It mentions "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed." This statement refers to performance testing but does not provide the details of such tests, acceptance criteria, or specific results, nor does it refer to an AI device.

Therefore, I cannot extract the following information from the provided document:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is for a traditional medical device (spinal system hardware), not an AI-powered diagnostic or predictive device, which is typically what would require the detailed performance study information you are asking for.

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